Trial document




drksid header

  DRKS00000092

Trial Description

start of 1:1-Block title

Title

Microsurgical versus minimal invasive approach (Metrix instrument), for lumbar disc herniation surgery: a randomized controlled trial on clinical outcome.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

MMILD

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Evaluation of influence of the microsurgical versus minimal invasive (Metrix) approaches on clinical results following lumbar disc herniation surgery.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The aim of the study is to evaluate the influence of the microsurgical versus minimal invasive (Metrix) approaches on clinical results following lumbar disc herniation surgery.
The study hypothesis is that the minimal invasive approach leads (a) to a reduction of postoperative pain, (b) to earlier hospital discharge, (c) to earlier working ability, (d) to better 2 years outcome.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000092
  •   2009/03/04
  •   [---]*
  •   yes
  •   Approved
  •   072/08, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M51.1 -  Lumbar and other intervertebral disc disorders with radiculopathy
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Conventional approach for lumbar disc herniation surgery
  •   minimal invasive (Metrix) approach for lumbar disc herniation surgery
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Reduction of postoperative pain

Low back and sciatic pain assessed by visual analog scale ([VAS], 0= no pain, 10=unbearable pain)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

(a) to earlier hospital discharge, (b) to earlier working ability, (c) to better 2 years outcome.

1)Oswestry Disability Questionaire.
2)Economical and healthy situation (Prolo-Scale).
3)Quality of life (SF-36).
4)Mental ability (german version of the Beck Depression Inventory (BDI)).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2009/04/01
  •   250
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

-Adults (>18 years) of both genders.
-Patients with monosegmental radicular compression syndrome due to lumbar disc herniation, indicated to be treated surgically.
-Patients have to be able to understand the study plan and give written informed consent.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

-Emergency indications for operation of lumbar disc herniations.
-Recurrent lumbar disc herniations.
-Additional lumbar disease (e.g. lumbar spinal stenosis od Spondylolisthesis).
-Patients non-consent to the study.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.